The purpose of this randomized, prospective trial is to determine wether (a) a once weekly glucose profile (self monitoring) or (b) a three-monthly report of the actual glycated haemoglobin are effective interventions to improve HbA1c after one year in typ 2-diabetic patients on conventional insulin treatment.

The design is an open, prospective, randomised, multicentre parallel group study. The total duration will be 5 years with patient recruitment over 4 years and an individual observation period of 1 year. 300 participants from 43 study centres, hospitals and private practices were recruited. The study will run for one year and aims to determine, whether there is an advantage with regard to HbA1c levels when (a) a regular three-monthly HbA1c or (b) a weekly 4-point glucose profile is taken and reported.

After screening, patients will be assigned at random to one of the following study arms:

no regular blood-glucose self-monitoring, no regular HbA1c

regular blood glucose self monitoring, no regular HbA1c

no regular blood glucose self monitoring, regular HbA1c

regular blood glucose self monitoring, regular HbA1c

The control for all participants is that urinary glucose should be monitored at least once a day, preferably in the late morning, as the highest increase in plasma glucose level occurs after breakfast.

Inability to perform study-related activities according to the present protocol

Pregnancy not certainly excluded

Abuse of alcohol and/or other drugs

Participation in other clinical trials during the past 3 month

Threat to general state of health

Intensified insulin therapy (at least 3 times rapid-acting insulin)

Frequent blood glucose self monitoring during the past 3 months (more than one 4-point glucose profile per week or more than one blood glucose/ urinary glucose test per day )

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688363